← Product Code [OSF](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OSF) · K093491 # HIP SEXTANT INSTRUMENT SYSTEM (K093491) _Surgical Planning Associates · OSF · Dec 9, 2010 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/OSF/K093491 ## Device Facts - **Applicant:** Surgical Planning Associates - **Product Code:** [OSF](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/OSF.md) - **Decision Date:** Dec 9, 2010 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic ## Intended Use The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures. ## Device Story Hip Sextant is a manual mechanical acetabular positioning device used during hip arthroplasty. Input data includes patient-specific pelvic CT mapping. Device features three legs that seat onto the pelvis to define a sextant plane; two adjustable protractors orient a direction pin to guide acetabular component placement. Surgeon performs procedure by placing a pin in the ischium, seating the cannulated leg and sextant, then seating remaining legs via arthroscopic trocars. An Excel spreadsheet assists the surgeon with alignment calculations. Device is used in the OR by surgeons. Output is a physical alignment guide for the cup impactor, facilitating precise component orientation. Benefits include improved surgical accuracy in hip reconstruction. ## Clinical Evidence Device performance supported by clinical experience and nonclinical testing. Nonclinical testing included sterilization validation, cleaning validation (including protein residual), and repeated autoclave wear testing. Software used for alignment calculations was validated. No specific clinical trial metrics (e.g., sensitivity, specificity) provided. ## Technological Characteristics Manual mechanical acetabular positioning device. Constructed of medical-grade biocompatible metal. Reusable. Features three-legged design for pelvic seating, two protractors for orientation, and a direction pin. Operates via manual mechanical alignment. Includes software (Excel spreadsheet) for alignment calculations. Sterilization via autoclave. ## Regulatory Identification A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. ## Predicate Devices - Wright Medical Acetabular Alignment Guide - Depuy Pinnacle Cup System - Stryker Acetabular Alignment Guide - Aufranc Universal Cup Alignment Guide - Protractors ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ # 510(k) Summary ## Device: Hip Sextant Instrument System (K093491) Submission Type: Traditional 510(k) DEC - 9 2010 Date Prepared [21 cFR 807.92(a)(1)]: Revised October 29, 2010 ### Submitter's Information [21 CFR 807.92(a)(1)] This 510(k) is being submitted by Orchid Design on behalf of Surgical Planning Associates, Inc. #### Contact: Curtis Raymond Orchid Design 80 Shelton Technology Center - Shelton, CT 06484 Tel: (203) 922-0105 - Fax: (203) 922-0130 e-mail: curt.raymond@orchid-orthopedics.com ## Sponsor / Manufacturer: Surgical Planning Associates, Inc 43 Riverside Avenue, #192 Medford, MA 02155 ## FDA Establishment Registration#: Pending Trade Name, Common Name, Classification (21 CFR 807.92(1)(2)) Device Trade Name: Hip Sextant Device Common, Usual, or Classification Names: - Orthopedic Stereotaxic System . - . Acetabular cup alignment guides - Acetubular Positioner ● - Socket positioned . - . Trocar Classification: Class 2; ref. 21 CFR 21 §882.4560 (OSF – Patient Specific Manual Orthopedic Stereotaxic System). {1}------------------------------------------------ #### Predicate Devices [21 CFR 807.92(a)(3)] - Wright Medical Acetabular Alignment Guide, Class 1 Exempt . - Depuy Pinnacle Cup System Class 1. Exempt . - Stryker Acetabular Alignment Guide, Class 1 Exempt . - Aufranc Universal Cup Alignment Guide Class 1 Exempt and . Preamendment - Protractors Class 1 exempt and Pre-amendment . The subject device as well as the predicate devices are composed of medical grade metal and reusable. The Depuy, Stryker, and Wright Medical instruments were design to be used with hip systems from the respective manufacturers. Both the Hip Sextant and the Aufranc Universal Cup Alignment Guide can be used during any hip reconstructive procedure regardless of the type of implant being used. Both the HipSextant device and Protractors have measurement numbers or indicators on the device to assist the surgeon with alignment. The other devices do not have such numeric indicators. #### Description of the Device [21 CFR 807.92(a)(4)] The HipSextant Instrument is a manual mechanical acetabular positioning device. The devices is used in conjunction with CT mapping of the individual patients pelvis. The instrument has three legs which land on the pelvis. The legs form three points which define the sextant plane. The sextant has two protractors that are adjusted to orientate a direction pin in the direction of the desired orientation of the acetabular component. During surgery a small pin is placed into the ischium and a cannulated leg and the sextant are seated onto the ischium. The second leg is seated onto the lateral side of the anterior spine by placing an arthroscopic style trocar through a cannula. Finally, a third leg is also seated using a trocar. With the sextant firmly docked onto the pelvis, the cup impactor is then aligned with the sextant direction pin. The device is used with an Excel spreadsheet which is used to assist the surgeon in performing calculations regarding alignment. #### Intended Use [21 CFR 807.92(a)(5)] The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures. {2}------------------------------------------------ ## Technological Characteristics [21 CFR 807.92(a){6}} Surgical Planning Associates, Inc. believes that the subject device is substantially equivalent to the cited predicate devices. These types of devices are typically exempt from 510(k). However, the subject device utilizes a nontraditional plane for the navigation of acetabular cup positioning, which we believe can be appropriately reviewed under a 510(k) notification. Nevertheless, the conclusion of substantial equivalency is based on the identical indications for use, design concept, level of surgical invasiveness, and that all cited instruments are metal and reusable. Equivalence is further substantiated by clinical and nonclinical data. ## Performance Data [21 cFR 807.92(b)(1)] The subject device is composed of medical grade biocompatible materials. The subject device has been subjected and successfully passed clinical and nonclinical testing including the following: - Sterilization Validation ● - Cleaning Validation (including protein residual) . - · . Repeated autoclave studies to evaluate performance and wear - Validation of software used in conjunction with the device to perform ● calculations. - Clinical experience . ## Conclusion 121 CFR 807.92(b)(3)1 We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate devices. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Surgical Planning Associates % Orchid Design Mr. Joseph Azary 80 Shelton Technology Center Medford, Massachusetts 02155 DEC - 9 2010 Re: K093491 Trade/Device Name: Hip Sextant Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OSF Dated: November 05, 2010 Received: November 08, 2010 Dear Mr. Azary: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be clevice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to Conninered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug. devices mat have been recuire approval of a premarket approval appiroval appin&ation (PMA). and Cosmetic Act (Act) that do not require to the general controls provisions of the Act. The You may, dicierore, market the devices, editories and the coursely of the productions of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adultieration. Ticase note: CDTCP doos not be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 acove). Existing major regulations affecting your device can be may be subject to addinonal controls. Encluding on Janes 800 to 898. In addition, FDA may found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition found in the Code of I ederal Regarations) publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA s issuation of a bucking of a backless with other requirements of the Act {4}------------------------------------------------ ## Page 2 - Mr. Joseph Azary or any Federal statutes and regulations administered by other Federal agencies. You must or any Federal statutes and regulations administered of ot registration and listing (21 comply with all the Act's requirements, including, but norsting of medical comply with all the Act 's requirements, merce reporting (reporting of medical CFR Part 807); labeling (21 CFR Part 801); medical device reguirements as CFR Part 807); labeling (21 CFR Part 807); pood manufacturing practice requirements as set device-related adverse events) (21 CFR 803); good manufacturing practices the elect device-related adverse evenis) (21 CFR Pat 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, the elec forth in the quality systems (QS) regulation (21-51-14) of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please s (1580) html (1980) (1992) (1988) (1988) (1988) (1980) hm for If you desire specific advice for your device on our called fires/ucm liness and lises of Compliance . Also deast go to http://www.da.gov/AboutrDA/Cchices of Compliance Also, please the Center for Devices and Radiological Health's (CDRH's) Office of Compliance of CDLCFP Part the Center for Devices and Radiongical riculties of the consemarket notification" (21 CFR Part note the regulation entitled, "Misbranding by reference varies vegalation (2 note the regulation entitled, "Misolanding of relevelse to premiers 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to CFR Part 803), please go to 110,://www.rad.governma.government of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the You may obtain other general information. on your Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 030-2641 01 (30) ijicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, incerely yours, Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: Indications for Use: K09 349/ Hip Sextant Instrument System The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures. Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Niel Reiden Gorman Page _1_ of _1_ (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices K093491 510(k) Number ________________________________________________________________________________________________________________________________________________________________ DEC - 9 2010 Page 3 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/OSF/K093491](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94neurological-surgical-devices/OSF/K093491) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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